Spots Global Cancer Trial Database for A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
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Trial Identification
Brief Title: A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Official Title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Study ID: NCT05625399
Conditions
Study Description
Brief Summary: The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dignity Health - St. Josephs Hospital and Medical Center, Phoenix, Arizona, United States
Local Institution - 0189, Springdale, Arkansas, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
UC Irvine Health, Orange, California, United States
Stanford Univ Med School Dept of Dermatology, Stanford, California, United States
The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Ft. Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Greenebaum Cancer Center University of Maryland, Baltimore, Maryland, United States
Mayo Clinic, Rochester, Minnesota, United States
Oncology Hematology West P.C. Nebraska Cancer Specialist, Omaha, Nebraska, United States
Rutgers CINJ, New Brunswick, New Jersey, United States
Cleveland Clinic, Cleveland, Ohio, United States
St. Lukes University Health Network, Easton, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Intermountain Medical Center Campus Location, Murray, Utah, United States
Inova Health Care Services, Fairfax, Virginia, United States
Local Institution - 0023, Caba, Buenos Aires, Argentina
Local Institution - 0042, Caba, Buenos Aires, Argentina
Local Institution - 0067, Caba, Buenos Aires, Argentina
Local Institution - 0070, Caba, Buenos Aires, Argentina
Local Institution - 0133, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0145, Caba, Ciudad Autonoma De Buenos Aires, Argentina
Local Institution - 0160, Rosario, Santa Fe, Argentina
Local Institution - 0057, Cordoba, , Argentina
Local Institution - 0020, Tucuman, , Argentina
North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
Orange Health Service, Orange, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia
Local Institution - 0184, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
University of Sydney - Melanoma Institute Australia MIA, Wollstonecraft, New South Wales, Australia
Sunshine Coast University Private Hospital, Birtinya, Queensland, Australia
Local Institution - 0183, Woodville South, South Australia, Australia
Bendigo Health - Bendigo Cancer Centre, Bendigo, Victoria, Australia
Local Institution - 0059, Box Hill, Victoria, Australia
Austin Hospital - Medical Oncology Unit, Heidelberg, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Latrobe Regional Health, Traralgon, Victoria, Australia
One Clinical Research, Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Local Institution - 0027, Graz, , Austria
Universitatsklinik fur Dermatologie der Paracelsus medizinischen Privatuniversitat Salzburg, Salzburg, , Austria
Department of Dermatology, University Hospital St. Poelten, St. Polten, , Austria
Medizinische Universitaet WienAKH, Dpt. of Dermatology, Wien, , Austria
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Grand Hôpital de Charleroi-Oncology & Hematology, Charleroi, , Belgium
Local Institution - 0036, Jette, , Belgium
CHU de Liege, Liege, , Belgium
Local Institution - 0177, Fortaleza, Ce, Brazil
Oncologia de Preciso e Personalizada, Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0147, Curitiba, Parana, Brazil
ONCOSITE -Centro de Pesquisa Clinica em Oncologia Ltda, Ijui, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora Da Conceicao, Porto Alegrelegre, RIO Grande DO SUL, Brazil
UPCO - Hospital de Clinicas de Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil
Hosptial Sao Lucas da PUC de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0179, Ondina, Salvador-BA, Brazil
Local Institution - 0132, Florianopolis, Santa Catarina, Brazil
Local Institution - 0182, Lages, Santa Catarina, Brazil
Hospital do Amor de Barretos, Barretos, Sao Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Sao Jose do Rio Preto, Sao Paulo, Brazil
Clinica de Oncologia Reichow, Blumenau, SC, Brazil
Local Institution - 0180, Santa Cecilia, Vitoria, Brazil
INCA- Instituto Nacional de Cancer Jose de Alencar Gomes da Silva, Rio De Janeiro, , Brazil
Local Institution - 0130, Sao Paulo, , Brazil
Tom Baker Cancer Centre (TBCC) - Alberta Health Services (AHS), Calgary, Alberta, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Hopital de l Enfant Jesus, Quebec, , Canada
James Lind Centro de Investigación del Cáncer, Temuco, Araucania, Chile
Local Institution - 0178, Puerto Montt, Los Lagos, Chile
Bradford Hill Centro de Investigacion Clnica, Recoleta, Metropolitana, Chile
Clinica San Carlos de Apoquindo, Santiago, Metropolitana, Chile
Fundacion Arturo Lopez Perez, Santiago, Metropolitana, Chile
Local Institution - 0010, Santiago, Metropolitana, Chile
Clinica Vespucio, Santiago, Metropolitana, Chile
Local Institution - 0142, Vitacura, Metropolitana, Chile
Centro de Estudios Clinicos SAGA SpA, Santiago de Chile, Providencia, Chile
Oncocentro Apys, Vina Del Mar, Valparaiso, Chile
Local Institution - 0176, Via Del Mar, Valparaso, Chile
Local Institution - 0152, Bogota, , Colombia
Local Institution - 0149, Medellin, , Colombia
Local Institution - 0150, Valledupar, , Colombia
Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze, Prague, NY, Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc FNOL, Olomouc, , Czechia
FN Ostrava, Ostrava Poruba, , Czechia
Fakultni Nemocnice Kralovske Vinohrady FNKV, Prague, , Czechia
Helsinki University Hospital HUS, Helsinki, , Finland
Pirkanmaan Sairaanhoitopiiri - Tampereen Yliopistollinen Sairaala Tampere University Hospital - Keskussairaala, Tampere, , Finland
Turku University Hospital, Turku, , Finland
Institut Claudius Regaud IUCT O, Toulouse, Cedex 9, France
Hopital Saint-Louis, Paris, Ile De France, France
Local Institution - 0127, Chambray-les-Tours, Indre-Et-Loire, France
CHU Lille - Hopital Huriez, Lille, Nord, France
Hotel Dieu CHU Nantes, Nantes Cedex 01, OH, France
Institut Gustave Roussy, Villejuif Cedex, Val-De-Marne, France
CHU Amiens-Picardie - Site Nord, Amiens, , France
Centre Hospitalier de la Cote Basque, Bayonne, , France
CHU de Bordeaux - Hopital Saint-Andre, Bordeaux, , France
Centre Hospitalier Universitaire de Clermont Ferrand, Clermont Ferrand Cedex 1, , France
CHU Dijon - Hopital Francois Mitterand, Dijon, , France
Local Institution - 0117, Marseille, , France
Local Institution - 0190, Marseille, , France
Hopital Lyon Sud, Pierre-Benite, , France
Centre Eugene Marquis, Rennes Cedex, , France
CHU de Rouen - Hopital Charles Nicolle, Rouen, , France
Local Institution - 0181, Saint Etienne, , France
Nationales Centrum fr Tumorerkrankungen NCT, Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Universittsklinikum Regensburg, Regensburg, Bayern, Germany
Elbe Klinikum Buxtehude, Buxtehude, Niedersachsen, Germany
Universitaetsklinikum Schleswig-Holstein, Luebeck, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin, Berlin, , Germany
Local Institution - 0136, Dortmund, , Germany
Local Institution - 0039, Erfurt, , Germany
Universitaetsklinikum Essen, Klinik fuer Dermatologie, Essen, , Germany
Universitaetsklinikum Frankfurt Main, Frankfurt, , Germany
Department of Dermatology, University hospital Giessen, Giessen, , Germany
Local Institution - 0135, Goettingen, , Germany
Universitaetsklinikum Hamburg Eppendorf - UKE, Dept of Dermatology (W14), Hamburg, , Germany
Local Institution - 0148, Koeln, , Germany
Local Institution - 0137, Ludwigshafen, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Dermatologie Venerologie und Allergologie - Standort Marburg, Marburg, , Germany
Johannes Wesling Medical Center Minden, Minden, , Germany
Local Institution - 0076, Munchen, , Germany
Studienambulanz Hautklinik Klinikum Nuernberg, Nuernberg, , Germany
Unviersitaetsmedizin Rostock, Rostock, , Germany
Studienzentrum Hautklinik Tuebingen, Tuebingen, , Germany
Emek Medical Center, Afula, , Israel
Local Institution - 0054, Jerusalem, , Israel
Rabin Medical Center, Petah-Tikvah, , Israel
Local Institution - 0035, Tel Hashomer, , Israel
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Milan, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari, , Italy
IRCCS Ospedale Policlinico San Martino, Genova, , Italy
Istituto Nazionale Tumori - Fondazione Pascale Italy, Napoli, , Italy
Ospedale S. Maria della Misericordia, Perugia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena, , Italy
Local Institution - 0001, Zapopan, Jalisco, Mexico
Local Institution - 0104, Monterrey, Nuevo Leon, Mexico
Local Institution - 0075, Ciudad de Mexico, Oaxaca, Mexico
Local Institution - 0174, Cancun, Quintana Roo, Mexico
Local Institution - 0131, Puebla, , Mexico
Local Institution - 0073, Queretaro, , Mexico
Nordland hospital HF, Bodo, , Norway
Sykehuset Ostfold Kalnes, Gralum, , Norway
Akershus University Hospital, Lørenskog, , Norway
Local Institution - 0155, Oslo, , Norway
Centrum Onkologii im. Prof. Franciszka Lukaszczyka, Bydgoszcz, Kujawsko-pomorskie, Poland
Pratia MCM Krakow, Krakow, Malopolskie, Poland
SPZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego, Opole, Opolskie, Poland
Poznan University of Medical Sciences, Poznan, Wiekopolskie, Poland
Local Institution - 0187, Bialystok, , Poland
Local Institution - 0185, Gliwice, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, , Poland
Local Institution - 0048, Wroclaw, , Poland
CH Universitario de A Coruñas, A Coruna, A Coruña, Spain
Onkologikoa Of San Sebastian, Donostia, Gipuzkoa, Spain
Institut Catala dOncologia, Badalona, , Spain
Hospital Universitario Valle de Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Local Institution - 0188, Granada, , Spain
Complejo Hospitalario de Jaen, Jaen, , Spain
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Local Institution - 0126, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Fundacin Instituto Valenciano de Oncologa, Valencia, , Spain
Hospital Universitario La Fe Hospital La Fe Campanar, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Local Institution - 0186, Zaragoza, , Spain
Karolinska Universitetssjukhuset - Solna, Solna, Stockholm, Sweden
Local Institution - 0157, Linkoeping, Vastergotland, Sweden
Skne University Hospital Lund, Lund, , Sweden
Local Institution - 0069, Uppsala, , Sweden
Inselspital Bern, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
UNIL-CHUV Lausanne, Lausanne, , Switzerland
Local Institution - 0085, London, Greater London, United Kingdom
The Royal Marsden NHS Foundation Trust, London, Greater London, United Kingdom
Oxford University Hospitals NHS Foundation Trust, Headington, Oxford, Oxfordshire, United Kingdom
Local Institution - 0087, Glasgow, Strathclyde, United Kingdom
Northern Centre for Cancer Care, Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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